Global Regulatory Pathways Drugs and Biologics; Adjunct Pool), Henry E. Riggs School of Applied Life Sciences

Global Regulatory Pathways for Drugs and Biologics (Adjunct Pool), Henry

E. Riggs School of Applied Life Sciences

The primary responsibility of the Adjunct Faculty member is teaching. We are seeking adjunct instructors to teach the following course at Keck Graduate Institute (KGI):

REG 6140 Global Regulatory Pathways for Drugs and Biologics (Spring semester, 1.5 credits)

This course provides a comprehensive overview of regulatory requirements and pathways for the development, approval, and commercialization of drugs and biologics (including biosimilars) outside the United States. The focus will be on key global markets including the European Union, India, Japan, and the broader Asia‑Pacific region. Students will explore region‑specific regulatory frameworks such as the European Medicines Agency (EMA) centralized procedure, India’s CDSCO processes, Japan’s PMDA review system, and regulatory trends in countries such as the China NMPA, South Korea MFDS, and Australia TGA.

The course will examine critical topics such as clinical trial authorization, marketing application requirements, quality and manufacturing compliance, pharmacovigilance obligations, and so‑called reliance pathways to speed market access and reduce duplication of effort. Global concurrent regulatory submissions are now no longer just a want, but an imperative business need. Emphasis will be placed on strategic considerations for global development programs, including multi‑regional clinical trials, harmonization efforts through ICH guidelines and differences that can impact timelines, costs, and market access.

Designed for students and professionals entering regulatory affairs or global drug development, this course equips learners with the foundational knowledge to navigate and manage regulatory activities in major ex‑U.S. jurisdictions.

The successful candidate must share in the mission of KGI and the Riggs School of Applied Life Sciences Programs. The Adjunct Faculty member reports directly to the Dean of the Riggs School and works collaboratively with the Program Directors and other faculty.

A minimum of a Master’s degree in a related field. A doctoral degree is strongly preferred. A minimum of 2 years of teaching experience. Prior experience in teaching for active learning preferred. Experience with the Canvas learning management system is a plus.

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* ** Individuals must possess knowledge, skills and abilities to successfully perform the essential function of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.

• Provides high-quality student instruction.
• Evaluates student performance (e.g., written assignments, examinations, in‑class activities).
• Provides remedial instruction, as needed.
• Other duties as assigned.

Individuals must possess knowledge, skills and abilities to successfully perform the essential function of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.

• Demonstrated ability to work effectively as a member of a team and collaboratively with other departments.
• Excellent interpersonal and communication skills, including the ability to effectively communicate, both verbally and in writing; possess the ability to listen to all points of view, build consensus, and inform others of policies and decisions.
• Demonstrated ability to analyze and present complex issues to…